Study of Methylnaltrexone in Opioid-Induced Constipation Patients

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Treatments: Analgesics, Opioid; Methylnaltrexone; Naltrexone

Criteria

Inclusion Criteria:

• A life expectancy of 3 month or more

• Qualifying patients received opioids for analgesia for 1 week or more and a stable regimen of opioids and laxatives for 3 or more days before study entry

• Patients had opioid-induced constipation with either fewer than three laxation during the preceding week and no clinically meaningful laxation (as determined by the in investigator ) within 24h before the first study dose or no clinically meaningful laxation within 48h before the first study dose

• During the two-week trail , patients would keep their life habits (dietary fiber , fluid intake and physical activity)

• Patients volunteered for the trail

• Women of childbearing potential had negative pregnancy tests. Both male and female patients need to take effective contraceptives to avoid pregnancy.

Exclusion Criteria:

• Constipation that was not primarily caused by opioids ( as determined by the investigator)

• Mechanical gastrointestinal obstruction, an indwelling peritoneal catheter, clinically active diverticular disease , fecal impaction , acute surgical abdomen , and fecal ostomy

• Patients had the surgery plan which would effect the results of pain assessment

• Patients had hypersensitivity to methylnaltrexone , naltrexone or naloxone or if any investigational drug or experimental product